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TIGes Harmonised eCTD Guidance
- The TIGes Harmonised eCTD guidance version 2.0 can be found here and Release notes
here
- The Technical validation of eCTD submissions for new MAAs in DCP - (start of pilot phase) can be found here - NEW (Feb 24 2012)
- The BPG for the use of eCTD in MRP/DCP version 3.0 can be found here - NEW (Nov 28 2011)
- eCTD validation criteria v3.1
TIGes Harmonised NeeS Guidance
- The TIGes Harmonised NeeS guidance document version 3.0 can be found here and Release notes here
Please note that the document no longer applies to the European Medicines Agency after 1st January 2010 however, as from this date eCTD is the mandatory format for eSubmissions and NeeS are no longer accepted for this procedure.
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